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Results For "adult"

1362 News Found

Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer
Drug Approval | October 26, 2023

Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer

Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients


USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent
Drug Approval | October 26, 2023

USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer


FDA approves only vaccine Penbraya for treatment of meningococcal disease in adolescents
Drug Approval | October 21, 2023

FDA approves only vaccine Penbraya for treatment of meningococcal disease in adolescents

The vaccine further advances Pfizer’s vaccine portfolio and builds on more than 20 years of expertise and knowledge in the prevention of meningococcal disease


Granules India receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules
Drug Approval | October 20, 2023

Granules India receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules

Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)


Need to include ASMD as a notified condition in the National Policy for rare diseases
Policy | October 20, 2023

Need to include ASMD as a notified condition in the National Policy for rare diseases

ASMD is highly variable and the age of onset, specific symptoms and severity of the disorder can vary dramatically from one person to another


Glenmark to launch a Triple-drug FDC of Teneligliptin + Dapagliflozin + Metformin in India for Type 2 diabetes
News | October 18, 2023

Glenmark to launch a Triple-drug FDC of Teneligliptin + Dapagliflozin + Metformin in India for Type 2 diabetes

Glenmark's Zita portfolio of medicines have been benefiting around 1.75 million Type 2 diabetic patients annually


Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib
Drug Approval | October 09, 2023

Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib

The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials


Zydus receives final approval from the USFDA for Sugammadex Single-Dose Vial
Drug Approval | October 09, 2023

Zydus receives final approval from the USFDA for Sugammadex Single-Dose Vial

Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide


Reclassify nicotine replacement therapies as prescription drugs, says Doctor
News | October 07, 2023

Reclassify nicotine replacement therapies as prescription drugs, says Doctor

NRT offers 50% higher success rate in quitting smoking compared to unassisted attempts


Briefs: Caplin Steriles, Zydus  and APL Healthcare
Drug Approval | September 20, 2023

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients